MDIC releases framework regarding real-world evidence generation and potential regulatory uses for in vitro diagnostics

The Medical Device Innovation Consortium’s (MDIC; VA, USA) Clinical Diagnostics program has released a final version of a framework document regarding the generation of real-world evidence for in vitro diagnostics, to help industry stakeholders consider when and how real-world data may be considered in the development and regulatory decision-making processes for these devices. The framework – entitled ‘Real-World Clinical Evidence Generation: Advancing Regulatory Science and Patient Access for In Vitro Diagnostics’ – builds on previously issued guidance from the US FDA's Center for Devices and Radiological Health (MD, USA), which discusses the use of real-world evidence to help support regulatory...